Progression Free Survival (PFS) Based on Central Radiology Assessment Per Kaplan-Meier [ Time Frame: From date of randomization to progression or death up to 18 months ]

PFS is defined as the time from randomization to the date of the first documented tumor progression as per modified RECIST 1.0 or death from any cause, whichever comes first. Progression is assessed by cat scan (CT) and/or magnetic resonance imaging (MRI).

Original Primary Outcome Measures ICMJE (submitted: February 1, 2012)

Time to Progression free survival (PFS) [ Time Frame: From date of randomization to the date of death ]

The estimated average duration from randomization date is at least 5-8.5 months until disease progression. PFS is defined as the time from randomization to the date of the first documented tumor progression as per modified RECIST 1.0 or death from any cause, whichever comes first. Progression is assessed by CT and/or MRI.

Overall Survival (OS) Using Kaplan-Meier [ Time Frame: Every visit from randomization up to 18 months ]

OS is defined as the time from the date of randomization to date of death due to any cause.

Overall Safety Evaluation of Everolimus Versus Placebo [ Time Frame: Every visit from randomization up to 5 years ]

The assessment of safety will be based mainly on the frequency and type of treatment emergent adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g. vital signs) will be considered as appropriate. Safety events will be graded using the CTCAE V4.03 (Common Terminology Criteria for Adverse Events).

FACT-G Total Score Over the Duration of the Study [ Time Frame: Every Visit from randomization up to 5 years ]

FACT-G is a self-assessed health-related quality of life questionnaire. The questionnaire is comprised of 27 questions, scored 0 to 4, examining physical, social/family, emotional, and functional well-being. Deterioration is defined as a decrease by at least 7 points compared to baseline.

Objective Response Rate (ORR) [ Time Frame: Every Visit from randomization up to 5 years ]

ORR will be assessed per modified RECIST 1.0. ORR is the proportion of patients with a best overall response of complete response (CR) or partial response (PR).

Disease Control Rate (DCR) [ Time Frame: 5 years ]

The estimated average treatment duration is at least 5-8.5 months until disease progression. DCR will be assessed per modified RECIST 1.0. DCR is the proportion of patients with best overall response of CR, PR or stable disease (SD).

Change in Chromogranin A (CgA) and Neuron Specific Enolase (NSE) Levels During the Study [ Time Frame: Every visit from baseline up to 5 years ]

The estimated average treatment duration is at least 5-8.5 months until disease progression. CgA and NSE are potential biomarkers for tumor response. Change from baseline will be noted and correlated with tumor response.

Time to Definitive Deterioration in WHO Performance Status Change During the Study [ Time Frame: Every visit up from randomization to 5 years ]

The estimated average duration is at least 5-8.5 months until disease progression. WHO Performance Status is a scale rated from 0 (normal) to 5 (dead) by a healthcare professional to assess the overall status of a patient. Deterioration is defined as an increase of at least one category compared to baseline.

Pharmacokinetics (PK) [ Time Frame: Visit 3 (Cycle 2, Study Day 29) ]

A single blood sample to determine the exposure of everolimus at the steady-state pre-dose concentration (Cmin).

Time to Overall survival (OS) [ Time Frame: From date of randomization to the date of death ]

The estimated average survival duration is at least 30 to 46 months from randomization date. OS is defined as the time from the date of randomization to date of death due to any cause.

Overall Safety Evaluation of Everolimus Versus Placebo [ Time Frame: Each visit from randomization up to 5 years ]

The estimated average survival duration is at least 30 to 46 months from randomization date.The assessment of safety will be based mainly on the frequency and type of treatment emergent adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g. vital signs) will be considered as appropriate. Safety events will be graded using the CTCAE V4.03 (Common Terminology Criteria for Adverse Events) which defines the severity of adverse events from Grade 0 (None) to Grade 4 (life-threatening consequences) and Grade 5 (Death due to AE).

Time to definitive deterioration in FACT-G total score over the duration of the study [ Time Frame: Every 2 - 3 months up to 5 years ]

The estimated average duration is at least 5-8.5 months until disease progression. FACT-G is a self-assessed health-related quality of life questionnaire. The questionnaire is comprised of 27 questions, scored 0 to 4, examining physical, social/family, emotional, and functional well-being. Deterioration is defined as a decrease by at least 7 points compared to baseline.

Time to Objective response rate (ORR) [ Time Frame: 5 years ]

The estimated average duration is at least 5-8.5 months until disease progression. ORR will be assessed per modified RECIST 1.0. ORR is the proportion of patients with a best overall response of complete response (CR) or partial response (PR).

Disease Control Rate (DCR) [ Time Frame: 5 years ]

The estimated average treatment duration is at least 5-8.5 months until disease progression. DCR will be assessed per modified RECIST 1.0. DCR is the proportion of patients with best overall response of CR, PR or stable disease (SD).

Change in Chromogranin A (CgA) and Neuron Specific Enolase (NSE) Levels During the Study [ Time Frame: Every visit from baseline up to 5 years ]

The estimated average treatment duration is at least 5-8.5 months until disease progression. CgA and NSE are potential biomarkers for tumor response. Change from baseline will be noted and correlated with tumor response.

Time to definitive deterioration inWHO Performance Status change during the study [ Time Frame: Every visit up from randomization to 5 years ]

The estimated average duration is at least 5-8.5 months until disease progression. WHO Performance Status is a scale rated from 0 (normal) to 5 (dead) by a healthcare professional to assess the overall status of a patient. Deterioration is defined as an increase of at least one category compared to baseline.

A Randomized, Double-blind, Multicenter, Phase III Study of Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced NET of GI or Lung Origin

Brief Summary

The purpose of this study is to compare the antitumor activity of everolimus plus best supportive care versus placebo plus best supportive care in patients with advanced nonfunctional neuroendocrine tumor of gastrointestinal or lung origin.

In addition to treatment-naive patients, patients previously treated with SSA, Interferon (IFN), one prior line of chemotherapy, and/or PRRT are allowed into the study. Pretreated patients must have progressed on or after the last treatment

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com